Edoxaban BOC amino acid impurity

Edoxaban BOC amino acid impurity is a synthetic byproduct arising from incomplete BOC deprotection during Edoxaban API synthesis. It features a tert-butyloxycarbonyl (BOC)-protected amino group linked to a hydroxylated aliphatic chain, with a core structure mirroring Edoxaban’s lysine-derived side chain. The compound retains the parent drug’s ethyl 5-(4-amidinophenyl)-5-oxopentanoate scaffold but incorporates a carbamate-protected amino terminus. This impurity is critical for validating HPLC methods to quantify residual BOC-protected intermediates in Edoxaban formulations.